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What is Protocol Manager (CTMS)?

The Protocol Manager plays a crucial role in clinical operations by managing global trials across different phases of drug, device, biologic, and vaccine development. It establishes essential Standard Operating Procedures (SOPs) to ensure adherence to FDA's 21 CFR part 11 regulations. Utilizing Web Services technology, the platform enables seamless and automatic integration with a variety of popular EDC and IVRS solutions. For systems that do not support Web Services, an export/import feature is provided to facilitate integration. This all-encompassing tool includes a robust tracking system and database, enabling effective management of diverse trial information and metrics, which significantly boosts operational efficiency. Furthermore, it allows organizations to uphold stringent oversight throughout the trial process, safeguarding data integrity and ensuring compliance at each phase. As a result, the Protocol Manager not only streamlines operations but also supports the successful execution of clinical trials by promoting transparency and accountability.

What is Medrio?

Since 2005, Medrio's Electronic Data Capture (EDC) platform and its complementary eClinical solutions like ePRO, RTSM, eConsent, and Direct Data Capture (DDC) have gained the trust of leading pharmaceutical, biotech, CRO, animal health, medical device, and diagnostic organizations. Our reputation is built on providing user-friendly solutions that enhance the efficiency and simplicity of clinical trials across all phases, sizes, and complexities. Users of Medrio can create their databases in an average of 2.8 weeks without needing any programming skills and can easily implement mid-study modifications with just a few clicks. With options ranging from add-on features to comprehensive service packages, Medrio delivers adaptable, modular solutions tailored to meet the precise needs of our clients, ensuring they receive only the services they require. Our cutting-edge software, combined with extensive training and support resources, has resulted in a remarkable 98% customer satisfaction rating, demonstrating our commitment to excellence in the clinical trial landscape. We continuously strive to innovate and improve our offerings to keep pace with the evolving needs of our users.

Media

Media

Integrations Supported

ClinVigilant
Mosio

Integrations Supported

ClinVigilant
Mosio

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Atlant Systems

Date Founded

2010

Company Location

United States

Company Website

atlantsystems.com

Company Facts

Organization Name

Medrio

Date Founded

2005

Company Location

United States

Company Website

www.medrio.com

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Electronic Data Capture

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

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